Safety and Tolerability of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder
| Autor: | James Groark, Lingfeng Yang, Robert L. Findling, Deborah Chiles, Sara Ramaker, Karen A. Tourian |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Time Factors Adolescent Vital signs Poison control Severity of Illness Index law.invention Suicidal Ideation Randomized controlled trial law Desvenlafaxine Succinate Severity of illness mental disorders Medicine Humans Pharmacology (medical) Child Depressive Disorder Major Dose-Response Relationship Drug business.industry Original Articles medicine.disease Cyclohexanols Antidepressive Agents Desvenlafaxine Psychiatry and Mental health Tolerability Pediatrics Perinatology and Child Health Major depressive disorder Female business medicine.drug |
| Popis: | The purpose of this study was to assess long-term safety and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) in children and adolescents with major depressive disorder (MDD).An 8 week, multicenter, open-label, fixed-dose study of children (ages 7-11 years) and adolescents (ages 12-17 years) with MDD was followed by a 6 month, flexible-dose extension study. Patients were administered desvenlafaxine 10-100 mg/day (children) or 25-200 mg/day (adolescents) for a total of 8 months. Treatment-emergent adverse events (AEs), withdrawals because of AEs, laboratory tests, vital signs, and the Columbia Suicide-Severity Rating Scale (C-SSRS) were collected. Eight month safety results from the lead-in plus extension studies are reported for extension study participants, using lead-in study day -1 as baseline.Forty patients were enrolled in both studies (20 children; 20 adolescents). Of those, four children and three adolescents withdrew because of AEs. Treatment-emergent AEs reported by three or more patients were upper abdominal pain (15%) and headache (15%) in children, and somnolence (30%), nausea (20%), upper abdominal pain (15%), and headache (15%) in adolescents. Negativism (oppositional behavior) in a child was the single serious AE reported. No deaths occurred during the lead-in or extension studies. Mean pulse rates demonstrated statistically significant increases from lead-in study baseline to final evaluation (children, +5.2 bpm; adolescents, +5.9 bpm; p≤0.05). No statistically significant change in blood pressure was observed at final evaluation. Two adolescents (0 children) reported suicidal ideation on the C-SSRS at screening assessment and during the lead-in and/or extension trials; one adolescent reported suicidal ideation after screening only.Long-term (8 month) treatment with desvenlafaxine was generally safe and well tolerated in depressed children and adolescents. |
| Databáze: | OpenAIRE |
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